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Angina pectoris was reported in 71 [2. Results from the adjuvant trial bone substudy, at 12 and 24 months demonstrated that patients receiving anastrozole had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving NOLVADEX (tamoxifen citrate) had a mean increase in both lumbar spine and total hip BMD compared to baseline. Ductal Carcinoma in Situ (DCIS) The type and frequency of adverse events in the NSABP B-24 trial were consistent with those observed in the other adjuvant trials conducted with NOLVADEX (tamoxifen citrate). Reduction in Breast Cancer Incidence in High Risk Women. In the NSABP P-1 Trial, there was an increase in five serious adverse effects in the NOLVADEX (tamoxifen citrate) group: endometrial cancer (33 cases in the NOLVADEX (tamoxifen citrate) group vs. The following table presents the adverse events observed in NSABP P-1 by treatment arm. Only adverse events more common on NOLVADEX (tamoxifen citrate) than placebo are shown. NSABP P-1 Trial: All Adverse Events % of Women NOLVADEX N=6681 PLACEBO N=6707 Self Reported Symptoms N=6441 1 N=6469 1 Hot Flashes 80 68 Vaginal Discharges 55 35 Vaginal Bleeding 23 22 Laboratory Abnormalities N=6520 2 N=6535 2 Platelets decreased 0. In the NSABP P-1 trial, 15. The following are the medical reasons for withdrawing from NOLVADEX (tamoxifen citrate) and placebo therapy, respectively: Hot flashes (3, steroid cycles injectable. In the NSABP P-1 trial, 8. On the NSABP P-1 trial, hot flashes of any severity occurred in 68% of women on placebo and in 80% of women on NOLVADEX (tamoxifen citrate). Severe hot flashes occurred in 28% of women on placebo and 45% of women on NOLVADEX (tamoxifen citrate). Vaginal discharge occurred in 35% and 55% of women on placebo and NOLVADEX (tamoxifen citrate) respectively; and was severe in 4. There was no difference in the incidence of vaginal bleeding between treatment arms. Pediatric Patients – McCune-Albright Syndrome. Mean uterine volume increased after 6 months of treatment and doubled at the end of the one-year study. A causal relationship has not been established; however, as an increase in the incidence of endometrial adenocarcinoma and uterine sarcoma has been noted in adults treated with NOLVADEX (see BOXED WARNING ), continued monitoring of McCune-Albright patients treated with NOLVADEX (tamoxifen citrate) for long-term effects is recommended. The safety and efficacy of NOLVADEX (tamoxifen citrate) for girls aged two to 10 years with McCune-Albright Syndrome and precocious puberty have not been studied beyond one year of treatment. The long-term effects of NOLVADEX (tamoxifen citrate) therapy in girls have not been established. Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, skin rash and headaches. Usually these have not been of sufficient severity to require dosage reduction or discontinuation of treatment. Very rare reports of erythema multiforme, Stevens-Johnson syndrome, bullous pemphigoid, interstitial pneumonitis, and rare reports of hypersensitivity reactions including angioedema have been reported with NOLVADEX (tamoxifen citrate) therapy. In some of these cases, the time to onset was more than one year.
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In the placebo group, one patient with FIGO Stage 1B cancer received radiation therapy and the patient with FIGO Stage IVB cancer received chemotherapy and hormonal therapy. During total follow-up, endometrial adenocarcinoma was reported in 53 women randomized to Nolvadex (30 cases of FIGO Stage IA, 20 were Stage IB, 1 was Stage IC, and 2 were Stage IIIC), and 17 women randomized to placebo (9 cases were FIGO Stage IA, 6 were Stage IB, 1 was Stage IIIC, and 1 was Stage IVB) (incidence per 1,000 women-years of 2. Some patients received post-operative radiation therapy in addition to surgery. Uterine sarcomas were reported in 4 women randomized to Nolvadex (1 was FIGO IA, 1 was FIGO IB, 1 was FIGO IIA, and 1 was FIGO IIIC) and one patient randomized to placebo (FIGO 1A); incidence per 1,000 women-years of 0. 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In the P-1 trial, endometrial sampling did not alter the endometrial cancer detection rate compared to women who did not undergo endometrial sampling (0. There are no data to suggest that routine endometrial sampling in asymptomatic women taking Nolvadex to reduce the incidence of breast cancer would be beneficial. Non-Malignant Effects on the Uterus: An increased incidence of endometrial changes including hyperplasia and polyps have been reported in association with Nolvadex treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the estrogenic properties of Nolvadex. There have been a few reports of endometriosis and uterine fibroids in women receiving Nolvadex. The underlying mechanism may be due to the partial estrogenic effect of Nolvadex. Ovarian cysts have also been observed in a small number of premenopausal patients with advanced breast cancer who have been treated with Nolvadex. 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